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A Phase II/III study of Mavrilimumab for the treatment of patients with COVID-19 pneumonia and hyperinflammation

Trial Profile

A Phase II/III study of Mavrilimumab for the treatment of patients with COVID-19 pneumonia and hyperinflammation

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 07 Apr 2020

At a glance

  • Drugs Mavrilimumab (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 07 Apr 2020 New trial record
    • 31 Mar 2020 According to a Kiniksa Pharmaceuticals media release, the company is engaging with the U.S. Food and Drug Administration (FDA) regarding the path forward for potential Phase 2/3 clinical development of mavrilimumab in COVID-19 pneumonia.

Trial Overview

Purpose

This Phase II/III trial will evaluate Mavrilimumab for the treatment of patients with COVID-19 pneumonia and hyperinflammation.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex not stated

Patient Inclusion Criteria

Patients with COVID-19 pneumonia

Trial Details

Organisations

  • Affiliations Kiniksa Pharmaceuticals

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase II/III
  • Location USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
MavrilimumabPrimary Drug Intravenous
-

Mavrilimumab

Trial History

Event Date Event Type Comment
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020
31 Mar 2020 Other trial event According to a Kiniksa Pharmaceuticals media release, the company is engaging with the U.S. Food and Drug Administration (FDA) regarding the path forward for potential Phase 2/3 clinical development of mavrilimumab in COVID-19 pneumonia. Updated 07 Apr 2020

References

  1. Kiniksa Pharmaceuticals. Kiniksa Announces Early Evidence of Treatment Response with Mavrilimumab in 6 Patients with Severe COVID-19 Pneumonia and Hyperinflammation. Media-Rel 2020;.

    Media Release
  2. Kiniksa Pharmaceuticals. Kiniksa Reports First Quarter 2020 Financial Results and Highlights Recent Corporate and Pipeline Activity. Media-Rel 2020;.

    Media Release
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